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The Essex MR Conditional CGA 870 pressure regulators are used with a portable oxygen delivery system intended to provide supplemental oxygen to adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and may be used during MR imaging for static magnetic fields of 3.0 T or less.

The Essex MR Conditional CGA 870 pressure regulator is designed to be installed on a medical CGA 870 post valve cylinder, regulate high pressure oxygen from 500 to 2,000 psig nominal, deliver a specific amount of oxygen to an attached flow selector, and be ignition resistant.
The device consists of:

• A yoke style inlet fitting per CGA 870.
• A pressure regulator section is to reduce the pressure from 500-2,000 psig to 50 psig nominal.
• A flow selector valve to control the flow at the regulated pressure between 0 and 25 L/min.
• Made of materials which meet the MR Conditional requirements of ASTM F2052-15.
  This is identical to our Class I, exempt model CGA 870 except for different materials to allow for the device to meet the ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.

This document is a 510(k) Pre-market Notification for a medical device called the "MR Conditional CGA 870" pressure regulator. The device is intended for use with portable oxygen delivery systems for adults in various healthcare settings, including during MRI imaging.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, clear format as would typically be found in a study report. Instead, it lists various non-clinical tests performed according to recognized standards. The "acceptance criteria" are implied by compliance with these standards, and the "reported device performance" is indicated by the statement that the device meets or is found to be substantially equivalent to these standards and the predicate device.

However, based on the Non-clinical Testing Summary and the Bench Testing sections, we can infer some criteria and the device's claimed performance:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested) for the non-clinical tests performed. It generally states that "a number of tests appropriate for the proposed device" were performed.
• Data Provenance: The tests are "Non-clinical Testing" and "Bench Testing," implying they were conducted in a laboratory setting by the manufacturer (Essex Industries, Inc.). The data is prospective in the sense that it was generated specifically for this 510(k) submission. There is no mention of country of origin for the data other than the manufacturer being based in the U.S.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes non-clinical, bench testing of a hardware device. Ground truth, in the context of expert review, typically applies to studies involving interpretation (e.g., medical imaging, clinical assessments) where human experts determine a definitive diagnosis or finding. For hardware performance, the "ground truth" is typically defined by the test methods and acceptance criteria within the referenced engineering standards.

4. Adjudication Method for the Test Set

This is not applicable for the same reason as above. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human assessment to resolve discrepancies in expert opinions. The testing described here is objective measurement against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. An MRMC study is a type of clinical comparative effectiveness study, usually for diagnostic devices, that assesses the performance of human readers (e.g., radiologists) with and without the assistance of a new diagnostic tool (often AI). The "MR Conditional CGA 870" is a physical medical device (pressure regulator) and not an AI-powered diagnostic tool, nor does it involve human readers for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This question pertains to the performance of artificial intelligence algorithms. The device described in the document is a mechanical pressure regulator.

7. The Type of Ground Truth Used

For this device, the "ground truth" for evaluating its performance is based on established engineering standards and specifications. The device's performance characteristics (e.g., pressure regulation, flow rates, mechanical resistance, ignition resistance, MR-conditionality) are measured directly against the quantifiable requirements outlined in standards like CGA E-4, CGA E-7, ISO 10524, EN 738-1, and ASTM F2052-15. Biocompatibility was assessed against relevant criteria (VOC and PM2.5).

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the evaluation of a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

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